Regulatory Affairs Cmc Manager in United States

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Job Purpose and Summary: At CVS Health, we are focused on transforming health care for our customers and making our company a great place to work. We help people navigate the health care system – and their personal health care – by improving access, lowering costs and being a trusted partner for every meaningful moment of health. Within our Retail locations, we bring this promise to life with heart every day. Our Pharmacy Managers play a critical role in cultivating a culture of excellence in their respective pharmacy by acting as a role model for all, demonstrating genuine care, and setting the bar for their pharmacy team. As a Pharmacy Manager, you will lead and develop a pharmacy team that provides exceptional patient care by promoting best practices and leading through change while identifying and addressing performance opportunities. Pharmacy Managers support novel program awareness, onboard newly hired pharmacy team members, and recognize colleagues for their success. The Pharmacy Manager consistently exhibits best practices when working the bench, including quarterbacking the team, providing patients with meaningful counseling, and abiding by all legal and regulatory guidelines, amongst other required activities. The Pharmacy Manager is responsible for direct and effective management of their pharmacy team, including but not limited to: Living our pur

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Job Purpose and Summary: At CVS Health, we are focused on transforming health care for our customers and making our company a great place to work. We help people navigate the health care system – and their personal health care – by improving access, lowering costs and being a trusted partner for every meaningful moment of health. Within our Retail locations, we bring this promise to life with heart every day. Our Pharmacy Managers play a critical role in cultivating a culture of excellence in their respective pharmacy by acting as a role model for all, demonstrating genuine care, and setting the bar for their pharmacy team. As a Pharmacy Manager, you will lead and develop a pharmacy team that provides exceptional patient care by promoting best practices and leading through change while identifying and addressing performance opportunities. Pharmacy Managers support novel program awareness, onboard newly hired pharmacy team members, and recognize colleagues for their success. The Pharmacy Manager consistently exhibits best practices when working the bench, including quarterbacking the team, providing patients with meaningful counseling, and abiding by all legal and regulatory guidelines, amongst other required activities. The Pharmacy Manager is responsible for direct and effective management of their pharmacy team, including but not limited to: Living our pur

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. The District Leader, Rx plays a critical role in cultivating a culture of clinical and business excellence in retail pharmacies across their market. With clinical and business oversight of approximately 20 retail pharmacies and an average team headcount of 200 reports, the District Leader, Rx has ultimate responsibility for patient safety and business success in their market. An inspiring coach and leader of people, the District Leader, Rx is focused on building and developing a team of Pharmacy Managers who grow the business through their consistent delivery of unparalleled care and patient connection. Specifically, the District Leader, Rx partners with and coaches their team to deliver on the core business with excellence, embrace change in an evolving healthcare ecosystem, and launch new products, programs, and services to keep our communities healthy. A licensed Pharmacist themselves, the District Leader, Rx brings deep knowledge of pharmacy workflow and clinical programs to help their teams identify and address performance opportunities, grow the top-line through the delivery of clinical services, and abide by all legal and regulatory guidelines with safety of our colleagues and patients top of mind. A model for all CVS Retail Pharmacists and Technicians, the District Leader, Rx also lives our Heart At Work behaviors, and sets the bar for Pharmacy Managers by their examples. To enable sustainable market su

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Job Purpose and Summary: At CVS Health, we are focused on transforming health care for our customers and making our company a great place to work. We help people navigate the health care system – and their personal health care – by improving access, lowering costs and being a trusted partner for every meaningful moment of health. Within our Retail locations, we bring this promise to life with heart every day. Our Pharmacy Managers play a critical role in cultivating a culture of excellence in their respective pharmacy by acting as a role model for all, demonstrating genuine care, and setting the bar for their pharmacy team. As a Pharmacy Manager, you will lead and develop a pharmacy team that provides exceptional patient care by promoting best practices and leading through change while identifying and addressing performance opportunities. Pharmacy Managers support novel program awareness, onboard newly hired pharmacy team members, and recognize colleagues for their success. The Pharmacy Manager consistently exhibits best practices when working the bench, including quarterbacking the team, providing patients with meaningful counseling, and abiding by all legal and regulatory guidelines, amongst other required activities. The Pharmacy Manager is responsible for direct and effective management of their pharmacy team, including but not limited to: Living our pur

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Omnicare is a leading provider of pharmacy services to long-term care facilities nationwide, supporting skilled nursing facilities, assisted living communities, and other institutional care settings. Following the sale of Omnicare by CVS Health, this role will support Omnicare and its continued operations as an independent, standalone organization. Candidates should be aware that this role will not remain within CVS Health following the transaction. The individual hired into this role will be employed by Omnicare and will contribute to shaping the future of our organization during this exciting period of growth and transformation. Position Summary: Looking for a career that rewards you? As a Back-End Pharmacy Technician with Omnicare, you will not only find rewarding work in your community, but a team focused on providing a supportive and innovative team environment for all members. Day In The Life: As an Back-End Pharmacy Technician, you will work to ensure all medication needs and regulatory standards are met for our patients. You will work in various workstations allowing you to grow your skillsets further. Our back-end team focuses on order fulfillment in our closed-door pharmacy setting, including packaging and dispensing of medication, reviewing delivery orders and bins for accuracy, and coordinating stock rotations. Additional tasks and responsibilities incl

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Omnicare is a leading provider of pharmacy services to long-term care facilities nationwide, supporting skilled nursing facilities, assisted living communities, and other institutional care settings. Following the sale of Omnicare by CVS Health, this role will support Omnicare and its continued operations as an independent, standalone organization. Candidates should be aware that this role will not remain within CVS Health following the transaction. The individual hired into this role will be employed by Omnicare and will contribute to shaping the future of our organization during this exciting period of growth and transformation. Position Summary: Are you a skilled Pharmacy Technician looking to advance your career? Looking to change into a closed-door pharmacy setting and gain new skillsets? Join our Omnicare closed-door pharmacy team as an Advanced Pharmacy Technician- and find a career that rewards you. Day In The Life: As an Advanced Pharmacy Technician, you will work to ensure all medication needs and regulatory compliance are met for our patients while working in various pharmacy workstations. Our back-end team focuses on order fulfillment including packaging and dispensing of medication, reviewing delivery orders and bins for accuracy, and coordinating stock rotations. Additional tasks and responsibilities include: Partnering with function

At Freddie Mac, our mission of Making Home Possible is what motivates us, and it’s at the core of everything we do. Since our charter in 1970, we have made home possible for more than 90 million families across the country. Join an organization where your work contributes to a greater purpose. Position Overview: At Freddie Mac, our mission of Making Home Possible is what motivates us, and it’s at the core of everything we do. Since our charter in 1970, we have made home possible for more than 90 million families across the country. Join an organization where your work contributes to a greater purpose. This role is in Governance and Business Services (GBS) and is part of 1st Line within the Multifamily Division at Freddie Mac in McLean, VA. GBS leads the division in managing operational risk, in compliance with the Corporate Enterprise Risk Management framework. As an Operational Risk & Controls Senior in GBS, you will support Multifamily Process Owners in managing third-party supplier risk by using an integrated approach to operational risk frameworks, collaborating with the 2nd line, 3rd line, and other business lines counterparts. You will engage with key business process owners to assess and monitor inherent risks associated with suppliers, ensuring compliance with regulatory standards and internal controls. This role also offers an excellent opportunity to gain insight into our Multifamily business. The responsibilities are time-sensitive and carry a high level of visibility both within the Multifamily division and across the company. Our Impact: Our team leads third-party risk management for the Multifamily division, serving as trusted advisors to business process owners. We ensure compliance with all corporate third-party risk policies, standards, and procedures, and proactively partner with stakeholders across all three lines to assess and mitigate supplier risks. We oversee

Associate Loads and Dynamics Engineer Company: The Boeing Company The Boeing Defense, Space & Security (BDS) organization is seeking an Associate Loads and Dynamics Engineer to support fixed-wing aircraft programs located in Berkeley, Missouri . As an Associate Loads & Dynamics Engineer, you will support loads and dynamics assessments for various aircraft programs within the Air Dominance division. This position requires strong analytical problem solving skills and familiarity with one or more of the following: external loads, structural dynamics, aeroelastic stability, aerodynamics, aircraft stability and control, and finite element modeling. The ability to effectively coordinate with teammates, internal suppliers, and customers is also required. Position Responsibilities Assist in developing air vehicle requirements Create vehicle-level models for loads and dynamics analysis Perform loads and dynamics analysis to support air vehicle design (e.g. flight and ground simulations for loads, flutter/divergence analysis, noise & vibration assessments) Assist in developing flight and ground test requirements and plans Support ground and flight testing by performing pre-test analysis, real-time monitoring of test conditions, post-processing of test data, and documentation of test results Support airworthiness activities with regulatory agencies and internal/external customers via correspondence, presentations, and documentation Assist in developing vehicle flight envelope and operational limits Basic Qualifications (Required Skills and Experience): Bachelor of Science degree in

The Clnt Onbrd Intmd Assoc Analyst is a developing professional role which integrates in-depth specialty knowledge with a solid understanding of industry standards and practices; demonstrates good understanding of how the team and area integrate with others in accomplishing the objectives of the subfunction/ job family. Applies analytical thinking and knowledge of data analysis tools and methodologies. Breaks down information in a systematic and communicable manner. Developed communication and diplomacy skills are required in order to exchange potentially complex/sensitive information. Moderate but direct impact through close contact with the businesses' core activities. Quality and timeliness of service provided will affect the effectiveness of own team and other closely related teams. Responsibilities: Responsible for a wide range of duties from account opening to account maintenance, to internal partner support with extensive client interface. Responsible for ensuring a smooth process in handling all of the aspects of on-boarding a client. Liaise with clients and internal teams in to ensure that time to market is minimized and that transparency can be provided around processes. Responsible for identifying opportunities to centralize and optimize processes to improve client satisfaction and the overall group performance. Support and monitor the timely and accurate execution of client and internal requests to the group. Provides additional support through the population of account opening, market opening and tax documentation, ensuring all documents are collected, verified and stored, and provide status back to the client. Perform client documentation searches across internal and external sites and compile client profiles. Interacts with client regarding the latest status and current on-boarding actions. Partner with internal teams to ensure regulatory reviews on all clients

Become a part of our caring community The Director, Provider Solutions Engineering devises an effective strategy for executing and delivering on IT business initiatives. We ask that you have an in-depth understanding of how organization capabilities interrelate across the function or segment. The Director, Provider Solutions Engineering serves as the strategic technology leader responsible for defining Humana's Provider engagement and engineering. In partnership with business and operational teams, this role is responsible to identify and implement strategic technology solutions that improve provider engagement, associate effectiveness, and business outcomes. The Director collaborates across a highly matrixed organization to establish technology strategy, drive large-scale transformation initiatives, and deliver modern customer relationship management capabilities that support the end-to-end provider experience. This leader is accountable for translating business priorities into actionable roadmaps, driving execution excellence, strengthening engineering discipline, and ensuring technology investments align with enterprise architecture, regulatory requirements, and organizational objectives. The role is responsible for establishing the future-state Provider engagement vision, accelerating AI-enabled capabilities, modernizing technology platforms, and fostering a high-performing engineering culture that consistently delivers measurable business value. Key Responsibilities Technology Leadership Serve as the strategic technology leader for Provider engagement and related provider experience capabilities. Partner effectively within a matrixed organization to align business priorities, regulatory requirements, architecture standards, and technology investments. Provide strategic dir

We anticipate the application window for this opening will close on - 30 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72&#43; million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Acute Care & Monitoring (ACM) business develops technologies that help clinicians monitor, assess, and manage patients across the continuum of care. This role supports ACM’s airway management portfolio, a product area focused on technologies used in acute care environments including operating rooms, intensive care units, and emergency departments. The engineering team partners across software, hardware, mechanical, systems, clinical, and quality functions to develop and sustain medical technologies that improve patient care and clinician workflows. This position is based in Lafayette, Colorado and is an onsite role. Limited travel may be required to support collaboration, testing activities, and business needs. As an Embedded Software Engineer II, you will develop embedded software solutions for medical devices used in airway management applications. This role combines software design, embedded systems development, hardware integration, testing, and technical documentation to support new product development and lifecycle engineering activities. You will collaborate with cross-functional teams to develop reliable software that meets product, quality, and regulatory requirements. Primary Responsibilities <li

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Clinical Program Manager is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. You will oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You will be responsible for the resource management of studies, includi

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description We are in search of an Associate Director , Statistical Programming to join our team! Statistical Programming– Analysis Programming: Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives. This is a HYBRID position at our Foster City, CA OR Raleigh, NC locations. This is NOT a fully remote position. Job Responsibilities: Works collaboratively with Clin

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Summary: Leads the Quality Engineering function responsible for independent oversight of the site validation program and governance of the plant data integrity program. Sets strategy, standards, risk tolerance, and performance expectations; ensures effective QA partnership with Engineering, Facilities, Operations, CSV, laboratories, and system owners; and represents the QA oversight of these programs to site leadership and regulatory agencies. The manager ensures accountable owners execute validation and remediation work while Quality Engineering personnel maintain independent review, approval, escalation, and governance. Essential Duties and Responsibilities: Establish and maintain the site strategy, governance model, procedures, and decision rights for independent QA oversight of validation and plant-level data integrity. Lead, develop, and performance-manage the Quality Engineering team; assign oversight based on project ri

A Career with Point72’s Technology Team As Point72 reimagines the future of investing, our Technology team is constantly evolving our firm’s IT infrastructure and engineering capabilities, positioning us at the forefront of a rapidly evolving technology landscape. We’re a team of experts who experiment and work to discover new ways to harness open-source solutions, modern cloud architectures, and sophisticated Artificial Intelligence (AI) solutions, while embracing enterprise agile methodologies. Our commitment to building and innovating in the AI space provides the framework intended to drive smarter decision making and enhance how we build and operate our platforms and applications. As a member of Point72’s Technology team, we encourage and support your professional development from day one—helping you advance your technical skills, contribute innovative ideas, and satisfy your own intellectual curiosity—all while delivering real business impact for our multi-billion-dollar global business. What you’ll do Develop and maintain the information security policy and standards library, aligning it with business priorities, regulatory expectations, and control objectives Lead independent assessments of the information security program, including regulatory examinations and third-party evaluations Identify technology risks across a complex business environment and drive mitigation aligned with our firm’s standards and control expectations Investigate data privacy inquiries and privacy-related events, assess business impact, and coordinate timely response activities Partner with technology, legal, compliance, and business stakeholders to translate risk findings into practical remediation plans Advise control owners on policy interpretation, risk treatment, and evidence expectations for assessments and examinations Prepare clear reports for management on team activity, emerging risks, remediation progress, and key decisions Maintain accurate risk, policy, priv